Sleep QualityROBO-PAWSNCT07603180
ROBO-PAWS: Robot-Dog-Assisted Walking
A study testing Robot-Dog-Assisted Walking in people with Sleep Quality and Fatigue, run by Koç University.
Trial summary
Childhood cancers affect approximately 400,000 children and adolescents worldwide each year. Although advances in treatment have significantly improved survival rates, children undergoing cancer treatment continue to experience a wide range of treatment-related symptoms and complications. Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Sleep Quality, Fatigue, Quality of Life
- What is being tested?
- Robot-Dog-Assisted Walking
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 2 and 7 years,
- Diagnosed with cancer and currently receiving active treatment,
- Pain level not severe enough to interfere with mobilization (FLACC or Wong-Baker FACES score ≤ 4),
- Diagnosed within the previous 1 month,
- Medically stable and approved by the physician to participate in light-intensity walking activities,
- Expected to remain hospitalized for at least 1 month to allow completion of the study protocol,
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- Not scheduled for hematopoietic stem cell transplantation (HSCT) and not currently undergoing HSCT,
- Hemoglobin level adequate for participation in walking activities (>10 g/dL),
- No significant impairment in consciousness, balance, or motor functions due to heavy analgesic or sedative medication use.
Who cannot join
- Resting SpO₂ <94%, requirement for ≥2 L/min oxygen support, or recurrent desaturation episodes within the last 24 hours,
- Heart rate or respiratory rate significantly elevated or irregular for age,
- Hemodynamic instability,
- Visual, hearing, or severe cognitive impairment that would prevent interaction with the robotic dog,
- Increased mobilization risk due to high-dose corticosteroid treatment or medications associated with neurotoxicity,
- Motor function limitations that would interfere with safe walking,
- Concurrent severe infection or serious treatment-related complications (e.g., grade 3-4 mucositis or severe neutropenia requiring isolation),
- Children receiving end-of-life care.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: ROBO-PAWS: A Pilot Randomized Controlled Trial of Robot-Dog-Assisted Walking to Improve Sleep Quality, Fatigue, and Quality of Life in Pediatric Oncology Patients
Childhood cancers affect approximately 400,000 children and adolescents worldwide each year. Although advances in treatment have significantly improved survival rates, children undergoing cancer treatment continue to experience a wide range of treatment-related symptoms and complications. Among these, fatigue and sleep disturbances are particularly common and may persist throughout treatment and survivorship, negatively affecting psychological well-being, cognitive functioning, and overall quality of life. Reduced physical activity during treatment is strongly associated with worsening fatigue, impaired sleep, and decreased quality of life in pediatric oncology patients. However, treatment side effects, prolonged hospitalization, infection risk, and lack of motivating play-based activities often limit children's participation in physical activity during treatment. Recent evidence suggests that physical activity interventions may help reduce fatigue and improve well-being in children with cancer, yet engaging and age-appropriate non-pharmacological interventions remain limited, especially for younger children.
This pilot randomized controlled trial aims to evaluate the feasibility and potential effects of a robot-dog-assisted walking intervention on sleep quality, fatigue, and quality of life among children aged 2-7 years undergoing cancer treatment.
Read the detailed description
This pilot randomized controlled trial will evaluate the feasibility and preliminary effects of a robot-dog-assisted walking intervention for children aged 2-7 years receiving active cancer treatment. The intervention is designed to promote physical activity through interactive and play-based walking sessions supported by a robotic dog companion.
Children undergoing cancer treatment frequently experience fatigue, sleep disturbances, reduced physical activity, and decreased quality of life during treatment. Hospitalization, treatment-related side effects, infection precautions, and limited access to motivating activities may contribute to sedentary behaviors in this population. Previous studies have suggested that physical activity interventions may improve symptom management and well-being in pediatric oncology patients; however, engaging and developmentally appropriate interventions for young children remain limited.
Participants will be randomly assigned to either the robot-dog-assisted walking intervention group or the control group receiving standard care. The intervention will consist of structured walking activities integrated into the child's routine during hospitalization or outpatient treatment visits. Feasibility outcomes will include recruitment, retention, adherence, acceptability, and safety of the intervention. Preliminary clinical outcomes will include sleep quality, fatigue, and quality of life.
The findings of this study will provide preliminary evidence regarding the feasibility and potential benefits of integrating robot-assisted play and movement interventions into supportive pediatric oncology care.
- Conditions
- Sleep Quality, Fatigue, Quality of Life
- Being tested
- Robot-Dog-Assisted Walking
- Keywords
- sleep quality, fatigue, children, cancer
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fatigue, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot-Dog-Assisted WalkingDevice
The intervention will use AIBO (Sony Interactive Entertainment, ERS-1000), an artificial intelligence-based robotic dog designed to support social interaction and engagement with children. AIBO is equipped with advanced sensors, interactive movement capabilities, microphones, speakers, and touch-responsive features that allow it to respond to voice commands, physical contact, and environmental stimuli. Its natural dog-like movements, facial expressions displayed through OLED eyes, and playful behaviors are intended to attract children's attention and encourage participation in walking activities. In addition, the device includes motion and distance sensors that enable safe navigation within the clinical environment.
Participants in the intervention group will receive standard medical and nursing care in addition to a robot-dog-assisted walking intervention using AIBO (Sony Interactive Entertainment, ERS-1000). Children will participate in supervised walking sessions twice daily (mornin
| Study group | Role | What they receive |
|---|---|---|
| ROBO-PAWS Group | Experimental | Children in the intervention group will receive standard care in addition to participating in robot-dog-assisted walking sessions twice daily (morning and evening) for one month. Each walking session will last 15 minutes and will be conducted within the clinical setting under the supervision of a nurse/researcher to ensure participant safety. The total daily walking duration will be 30 minutes.
Before the intervention and after completion of the intervention period, parents will complete questionnaires assessing sleep quality, quality of life, and fatigue. If the child experiences fatigue, dizziness, discomfort, or any other adverse symptoms during the walking sessions, the intervention will be immediately discontinued. The robotic dog will be disinfected before each use to maintain hygiene and infection control standards. Receives: Device: Robot-Dog-Assisted Walking |
| Control Group | No intervention | Children in the control group will receive standard medical treatment and routine nursing care only. Within routine clinical practice, children are allowed to leave their rooms and walk freely when they wish, although they are generally on bed rest for most of the day. They may also participate in unstructured playroom activities such as reading books, drawing, or playing games. However, no structured or supervised physical activity program aimed at increasing physical activity levels is routinely provided. Therefore, children in the control group will continue their usual daily activities within the standard clinical care environment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Sleep quality will be assessed using the Visual Sleep Scale (VSS), a child-friendly visual instrument developed for pediatric populations. The scale is rated from 1 ("Very Poor") to 10 ("Very Good") and includes visual cues such as sad, neutral, and smil
Measured: Baseline (Day 1, prior to intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).
Health-related quality of life
Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL), a validated 23-item instrument designed for children and adolescents aged 2-18 years. The scale evaluates physical, emotional, social, and school functioning. Items are scored on a 0-100 scale, with higher scores indicating better perceived quality of life. Total Scale Score, Physical Health Summary Score, and Psychosocial Health Summary Score will be calculated. Parent proxy-reports will be used in this study.
Measured: Baseline (Day 1, before intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).
Secondary outcomes (1)
Fatigue
Fatigue will be assessed using the Visual Fatigue Scale, a single-item self-report measure developed to evaluate fatigue severity. The scale ranges from 0 ("No fatigue") to 10 ("Severe and overwhelming fatigue"). Higher scores indicate greater fatigue severity. The instrument has demonstrated acceptable validity and reliability in clinical populations and will be used to monitor changes in fatigue levels throughout the intervention period.
Measured: Baseline (Day 1, prior to intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study will be conducted as a parallel-group, two-arm pilot randomized controlled trial with blinded outcome assessors/data analysts.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eysan Hanzade Umac, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603180
- Sponsor's protocol ID
- KOCUNV
- Acronym
- ROBO-PAWS
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROBO-PAWS: A Pilot Randomized Controlled Trial of Robot-Dog-Assisted Walking to Improve Sleep Quality, Fatigue, and Quality of Life in Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT07603180
- Acronym / sponsor ID
- ROBO-PAWS / KOCUNV
- Conditions
- Sleep Quality, Fatigue, Quality of Life
- Keywords
- sleep quality, fatigue, children, cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Childhood cancers affect approximately 400,000 children and adolescents worldwide each year. Although advances in treatment have significantly improved survival rates, children undergoing cancer treatment continue to experience a wide range of treatment-related symptoms and complications. Among these, fatigue and sleep disturbances are particularly common and may persist throughout treatment and survivorship, negatively affecting psychological well-being, cognitive functioning, and overall quality of life. Reduced physical activity during treatment is strongly associated with worsening fatigue, impaired sleep, and decreased quality of life in pediatric oncology patients. However, treatment side effects, prolonged hospitalization, infection risk, and lack of motivating play-based activities often limit children's participation in physical activity during treatment. Recent evidence suggests that physical activity interventions may help reduce fatigue and improve well-being in children with cancer, yet engaging and age-appropriate non-pharmacological interventions remain limited, especially for younger children.
This pilot randomized controlled trial aims to evaluate the feasibility and potential effects of a robot-dog-assisted walking intervention on sleep quality, fatigue, and quality of life among children aged 2-7 years undergoing cancer treatment.
Detailed description
This pilot randomized controlled trial will evaluate the feasibility and preliminary effects of a robot-dog-assisted walking intervention for children aged 2-7 years receiving active cancer treatment. The intervention is designed to promote physical activity through interactive and play-based walking sessions supported by a robotic dog companion.
Children undergoing cancer treatment frequently experience fatigue, sleep disturbances, reduced physical activity, and decreased quality of life during treatment. Hospitalization, treatment-related side effects, infection precautions, and limited access to motivating activities may contribute to sedentary behaviors in this population. Previous studies have suggested that physical activity interventions may improve symptom management and well-being in pediatric oncology patients; however, engaging and developmentally appropriate interventions for young children remain limited.
Participants will be randomly assigned to either the robot-dog-assisted walking intervention group or the control group receiving standard care. The intervention will consist of structured walking activities integrated into the child's routine during hospitalization or outpatient treatment visits. Feasibility outcomes will include recruitment, retention, adherence, acceptability, and safety of the intervention. Preliminary clinical outcomes will include sleep quality, fatigue, and quality of life.
The findings of this study will provide preliminary evidence regarding the feasibility and potential benefits of integrating robot-assisted play and movement interventions into supportive pediatric oncology care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This study will be conducted as a parallel-group, two-arm pilot randomized controlled trial with blinded outcome assessors/data analysts.
| Arm | Type | Receives |
|---|---|---|
| ROBO-PAWS Group | Experimental | Device: Robot-Dog-Assisted WalkingChildren in the intervention group will receive standard care in addition to participating in robot-dog-assisted walking sessions twice daily (morning and evening) for one month. Each walking session will last 15 minutes and will be conducted within the clinical setting under the supervision of a nurse/researcher to ensure participant safety. The total daily walking duration will be 30 minutes. Before the intervention and after completion of the intervention period, parents will complete questionnaires assessing sleep quality, quality of life, and fatigue. If the child experiences fatigue, dizziness, discomfort, or any other adverse symptoms during the walking sessions, the intervention will be immediately discontinued. The robotic dog will be disinfected before each use to maintain hygiene and infection control standards. |
| Control Group | No intervention | –Children in the control group will receive standard medical treatment and routine nursing care only. Within routine clinical practice, children are allowed to leave their rooms and walk freely when they wish, although they are generally on bed rest for most of the day. They may also participate in unstructured playroom activities such as reading books, drawing, or playing games. However, no structured or supervised physical activity program aimed at increasing physical activity levels is routinely provided. Therefore, children in the control group will continue their usual daily activities within the standard clinical care environment. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Aged between 2 and 7 years,
- Diagnosed with cancer and currently receiving active treatment,
- Pain level not severe enough to interfere with mobilization (FLACC or Wong-Baker FACES score ≤ 4),
- Diagnosed within the previous 1 month,
- Medically stable and approved by the physician to participate in light-intensity walking activities,
Key exclusion criteria (8 listed)
- Resting SpO₂ <94%, requirement for ≥2 L/min oxygen support, or recurrent desaturation episodes within the last 24 hours,
- Heart rate or respiratory rate significantly elevated or irregular for age,
- Hemodynamic instability,
- Visual, hearing, or severe cognitive impairment that would prevent interaction with the robotic dog,
- Increased mobilization risk due to high-dose corticosteroid treatment or medications associated with neurotoxicity,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robot-Dog-Assisted WalkingThe intervention will use AIBO (Sony Interactive Entertainment, ERS-1000), an artificial intelligence-based robotic dog designed to support social interaction and engagement with children. AIBO is equipped with advanced sensors, interactive movement capabilities, microphones, speakers, and touch-responsive features that allow it to respond to voice commands, physical contact, and environmental stimuli. Its natural dog-like movements, facial expressions displayed through OLED eyes, and playful behaviors are intended to attract children's attention and encourage participation in walking activities. In addition, the device includes motion and distance sensors that enable safe navigation within the clinical environment. Participants in the intervention group will receive standard medical and nursing care in addition to a robot-dog-assisted walking intervention using AIBO (Sony Interactive Entertainment, ERS-1000). Children will participate in supervised walking sessions twice daily (mornin | Device | ROBO-PAWS Group |
Primary outcome
Sleep quality
Time frame: Baseline (Day 1, prior to intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).
Sleep quality will be assessed using the Visual Sleep Scale (VSS), a child-friendly visual instrument developed for pediatric populations. The scale is rated from 1 ("Very Poor") to 10 ("Very Good") and includes visual cues such as sad, neutral, and smil
Health-related quality of life
Time frame: Baseline (Day 1, before intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).
Health-related quality of life will be assessed using the Pediatric Quality of Life Inventory (PedsQL), a validated 23-item instrument designed for children and adolescents aged 2-18 years. The scale evaluates physical, emotional, social, and school functioning. Items are scored on a 0-100 scale, with higher scores indicating better perceived quality of life. Total Scale Score, Physical Health Summary Score, and Psychosocial Health Summary Score will be calculated. Parent proxy-reports will be used in this study.
1 secondary outcome
Fatigue
Time frame: Baseline (Day 1, prior to intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. No individual participant data (IPD) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Robot-Dog-Assisted Walking in people with Sleep Quality and Fatigue, run by Koç University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Remziye Semerci Şahin, PhD (+90 535 011 2821, remziyesemerci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: Baseline (Day 1, prior to intervention initiation) and Week 4 (post-intervention assessment after completion of the 4-week intervention period).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.